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The Pioneer Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Pioneer Lateral Plate System consists of an assortment of plates and screws manufactured from ASTM F136 Titanium Alloy.

The provided document describes a Pioneer Lateral Plate System, a medical device used for spinal fixation. This is a mechanical device, not an AI/ML powered diagnostic or prognostic tool. Therefore, many of the requested categories related to AI/ML studies (such as sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable and will not be found in the document.

The performance data for this type of device focuses on mechanical testing and demonstrating substantial equivalence to predicate devices based on physical characteristics and intended use.

Here's the information extracted from the provided text:

Acceptance Criteria and Device Performance

Note: The document states that the test results demonstrate the device "functioned as intended and performed in a manner substantially equivalent to that of predicate systems." It does not provide specific numerical thresholds for acceptance or numerical results for the performance, as is common for substantial equivalence claims based on established ASTM standards for mechanical devices.

Information Not Applicable or Not Found in the Document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for mechanical testing of a spinal implant. The "test set" here refers to the physical devices subjected to mechanical stress tests, not a dataset of patient information.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of this device, is defined by the physical properties and performance against ASTM standards, not by expert interpretation of data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable for a mechanical spinal implant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the specifications of the ASTM standards and the physical properties of the materials and design.
7. The sample size for the training set: Not applicable. There is no training set for a mechanical device.
8. How the ground truth for the training set was established: Not applicable.

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The Streamline MIS Cannulated System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of the implants after the attainment of a solid fusion.

The Streamline MIS Cannulated System consists of rods, pedicle screws, connectors, and set screws used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The Streamline MIS Cannulated System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lower thoracic and/or lumbar spine during open or percutaneous spinal procedures. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Screws, Set Screws, Rods and Connecting components are comprised of Titanium Alloy per ASTM F 136.

The provided text describes a 510(k) summary for the Streamline MIS Cannulated System, a medical device for spinal fixation. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for the mechanical performance testing. It refers to "testing" and "test results" in a general sense. When a 510(k) submission states that engineering tests were run in accordance with a specified ASTM standard, the sample sizes are taken from that standard. However, the exact sample sizes used for each test are not explicitly detailed in this summary.
• Data Provenance: The data is generated from mechanical laboratory testing performed by Pioneer Surgical Technology. The data provenance is internal to the manufacturer. It is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in the typical sense for patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This information is not applicable to this type of submission. The "ground truth" for mechanical testing is established by objective measurements against engineering standards (ASTM F1717) and internal protocols, not by expert consensus or interpretations of patient data.

4. Adjudication Method for the Test Set

• This information is not applicable to this type of submission. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving human interpretation or assessments, not for mechanical laboratory testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This submission is for a spinal fixation device, and the evaluation is based on mechanical substantial equivalence, not on the interpretative performance of a diagnostic algorithm or the effectiveness of human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone study was not done. This device is a physical medical implant, not an algorithm or AI system. Therefore, the concept of algorithm-only performance is not relevant.

7. Type of Ground Truth Used

• The "ground truth" used for this submission is based on established engineering standards (ASTM F1717) for mechanical properties and internal protocols for specific component performance. The performance of the Streamline MIS Cannulated System was compared to the performance of predicate devices against these established benchmarks.

8. Sample Size for the Training Set

• This information is not applicable. There is no "training set" in the context of this 510(k) submission, as it is not an AI/ML algorithm or a diagnostic device that requires training on data. The device's design and manufacturing processes are validated, and its performance is verified through physical testing.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable, as there is no "training set" for this type of medical device submission.

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The Preference Pedicle Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Preference Pedicle Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Preference Pedicle Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the Preference Pedicle Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The Preference Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, hooks, connectors and rods. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli) or Cobalt Chrome.

The provided text describes a 510(k) premarket notification for the Preference Pedicle Screw System. It focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance criteria against predefined acceptance thresholds. Therefore, much of the requested information about acceptance criteria, study details, and ground truth establishment is not available in the provided document.

Here's a breakdown of the available and unavailable information:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document mentions "pre-clinical testing" but does not detail the number of units tested (e.g., for mechanical strength, fatigue).
• Data Provenance: The testing was "pre-clinical," meaning it was likely laboratory-based (in-vitro) or potentially animal studies, but the exact location (e.g., country of origin of the data) is not specified. It is not explicitly stated if it was retrospective or prospective, but pre-clinical testing is typically prospective in its design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This device is a pedicle screw system, a mechanical implant. Performance is evaluated through engineering and materials testing, not typically through ground truth established by medical experts in the way an AI diagnostic device would be.

4. Adjudication method for the test set:

• Not Applicable. As above, this is a mechanical device, not a diagnostic one requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable. This is a physical medical device (pedicle screw system), not an algorithm or AI.

7. The type of ground truth used:

• Not Applicable in the traditional sense. For mechanical devices, "ground truth" would relate to engineering standards, material properties, and biomechanical performance data. For instance, the "truth" is that the device can withstand certain loads or stresses without failure according to established physical criteria. The document only broadly states "pre-clinical testing."

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

In summary:

The provided document is a 510(k) summary for a physical medical device (pedicle screw system). The regulatory pathway for such devices largely relies on demonstrating substantial equivalence to already approved predicate devices through non-clinical performance testing (e.g., mechanical, material, and biocompatibility testing). It does not involve the kind of clinical study and performance metrics common for AI/ML-based diagnostic devices, which would require detailed information on acceptance criteria, ground truth, expert adjudication, and reader studies. The "performance testing" mentioned in the document refers to these pre-clinical tests, the details of which are not included in this summary but would have been part of the full 510(k) submission.

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